Nuove linee guida ESC sulla terapia antiaggregante. Riccardo Raddino

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1 UNIVERSITÀ DEGLI STUDI DI BRESCIA DIPARTIMENTO DI SPECIALITA MEDICO-CHIRURGICHE, SCIENZE RADIOLOGICHE E SANITA PUBBLICA Nuove linee guida ESC sulla terapia antiaggregante Riccardo Raddino

2 2015 ESC NSTE-ACS Guidelines NSTE-ACS European Heart Journal 2015; doi: /eurheartj/ehv320

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4 Efficacia e sicurezza della DAPT : 20 anni di studi

5 PERCHE MANTENERE LA DAPT DOPO 1 EVENTO ACUTO? Evidenza di vulnerabilità delle placche per almeno 12 mesi Angiographic & angioscopic images in a 58-year-old man with anterior MI [Asakura 2001] Multiple vulnerable plaques detected in non-culprit segments 1 7 Culprit lesion (#8) detected with thrombus (red) Multiple vulnerable plaques detected in non-culprit segments ACS, acute coronary syndrome; MI, myocardial infarction. Asakura M et al. J Am Coll Cardiol 2001;37: (with permission). AZ Medical Internal Use Only

6 Cumulative rate of MACE (%) La recidiva di eventi coronarici dopo 1 evento indice può derivare sia dalla culprit che dalle alter placche non culprit nell albero coronarico PROSPECT study: Prospective study of the natural history of atherosclerosis over 3 years in patients with ACS who underwent PCI (n=697)[stone 2011] All events 20.4% 15 Culprit lesion-related events 12.9% 10 Non-culprit lesion-related events 11.6% 5 Indeterminate events 2.7% Time from PCI (years) ACS, acute coronary syndrome; MACE, major adverse cardiac events; PCI, percutaneous coronary intervention; PROSPECT, Providing Regional Observations to Study Predictors of Events in the Coronary Tree. Stone GW et al. N Engl J Med 2011;364:

7 La sindrome coronarica acuta non è che la punta dell iceberg della malattia aterosclerotica ACUTE PLAQUE RUPTURE ACS (UA/NSTEMI/STEMI) ACS, acute coronary syndrome; NSTEMI, non-st segment elevation myocardial infarction; STEMI, ST segment elevation myocardial infarction; UA, unstable angina. Goldstein JA. J Am Coll Cardiol 2002;39: AZ Medical Internal Use Only

8 L importanza della stratificazione del rischio ischemico ed emorragico

9 L importanza della stratificazione del rischio emorragico (PRECISE-DAPT) e ischemico (DAPT) PRECISE-DAPT = PREdicting bleeding Complications In patients undergoing Stent implantation and subsequent Dual Anti Platelet Therapy;

10 QUALE ANTIAGGREGANTE? ACS: sia NSTE-ACS sia STE-ACS SCAD

11 PROVVEDIMENTI PERIPROCEDURALI PER RIDURRE I RISCHI EMORRAGICI

12 Switching tra i diversi inibitori orali di P2Y12

13 SINDROME CORONARICA ACUTA

14 MALATTIA CORONARICA STABILE

15 ALGORITMI PER LA GESTIONE DELLA DAPT NEI PAZIENTI CON MALATTIA CORONARICA

16 PTCA

17 BPAC

18 Terapia medica

19 Timing della sospensione dei diversi inibitori orali di P2Y12 nella chirurgia maggiore non cardiaca

20 20 In alcuni pazienti andrebbe considerato (IIbA) il prolungamento della DAPT

21 21 AHA/ACC expert consensus document on DAPT 2016

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23 PEGASUS-TIMI 54: Study Design Patients aged 50 years with a history of spontaneous MI 1 3 years prior to enrolment AND at least one additional atherothrombosis risk factor* (N=21,162) Ticagrelor 90 mg bid + ASA mg/day Ticagrelor 60 mg bid + ASA mg/day Placebo + ASA mg/day Minimum of 12 months follow up: Every 4 months in Year 1, then semi-annually Primary efficacy endpoint: CV death, MI or stroke Primary safety endpoint: TIMI-defined major bleeding *Age 65 years, diabetes mellitus, second prior MI, multivessel CAD or chronic non-end stage renal disease bid, twice daily; CAD, coronary artery disease; TIMI, Thrombolysis in Myocardial Infarction Bonaca MP et al. Am Heart J 2014;167: Bonaca MP et al. N Engl J Med 2015 [Epub ahead of print]

24 Key inclusion and exclusion criteria Age 50 years Key inclusion At least 1 of the following: Age 65 years Diabetes requiring medication 2nd prior MI (>1 year ago) Multivessel CAD Chronic, non-end stage renal dysfunction (CrCl <60 ml/min, Cockcroft Gault equation) Tolerating ASA and able to be dosed at mg/d Key exclusion Planned use of P2Y 12 antagonist, dipyridamole, cilostazol, or anticoagulant Bleeding disorder History of ischaemic stroke, ICH, CNS tumour or vascular abnormality Recent GI bleed or major surgery At risk for bradycardia Dialysis or severe liver disease CrCl, creatinine clearance; GI, gastrointestinal; ICH, intracranial haemorrhage Bonaca MP et al. Am Heart J 2014;167:

25 PEGASUS-TIMI 54: Primary Endpoint CI, confidence interval; HR, hazard ratio Bonaca MP et al. N Engl J Med 2015 [Epub ahead of print] In PEGASUS-TIMI 54, long-term treatment with ticagrelor significantly reduced the risk of the composite of CV death, MI or stroke by 15 16% in patients with a prior MI* within the previous 1 3 years

26 3-year KM event rate PEGASUS-TIMI 54: Bleeding P< P< Ticagrelor 90 mg bid Ticagrelor 60 mg bid Placebo P=NS P=NS P=NS TIMI major bleeding TIMI minor bleeding Fatal bleeding or ICH ICH Fatal bleeding Rates are presented as 3-year Kaplan-Meier estimates P<0.026 indicates statistical significance Bonaca MP et al. N Engl J Med 2015 [Epub ahead of print]

27 ANALISI DEI SOTTOGRUPPI: La riduzione dell end point primario (CV death, MI or stroke) è tanto maggiore quanto minore è il tempo trascorso dalla sospensione della DAPT

28 L EMA ha approvato l utilizzo di Ticagrelor 60 mg x 2/die in pazienti che hanno sospeso Ticagrelor 90 mg dopo almeno 1 anno di terapia; il trattamento con Ticagrelor 60 mg può essere iniziato SENZA sospendere Ticagrelor 90 mg. A CHI? QUANDO? PERCHE?

29 UNIVERSITÀ DEGLI STUDI DI BRESCIA DIPARTIMENTO DI SPECIALITA MEDICO-CHIRURGICHE, SCIENZE RADIOLOGICHE E SANITA PUBBLICA Grazie Riccardo Raddino